FDA Issues Another Form 483 to Biocon Over Its Insulin Facility

Biosimilar developer Biocon is facing yet another setback after the FDA issued another Form 483 for its insulin facility.

Biosimilar developer Biocon is facing yet another setback after the FDA issued another Form 483 for its insulin facility.

The manufacturing plant in Malaysia where Biocon will produce its insulin glargine product, referencing Sanofi’s Lantus, was the subject of a preapproval inspection between June 24 and July 5, 2019.

According to a company spokesperson, the inspection across the 3 units of the facility resulted in 12 observations noted in the Form 483.

Biocon did not elaborate on the nature of the observations. However, according to the spokesperson, “We will respond to the FDA with a Corrective and Preventive Action Plan and are confident of addressing these observations expeditiously. We do not expect any change to our commercialization plans for insulin glargine in the US. Biocon remains committed to global standards of quality and compliance.”

This is not the first time Biocon’s plants have been subject to regulatory issues, although the majority of those have since been resolved. Biocon’s Malaysian plant has been the subject of numerous regulatory challenges; in February 2018, the FDA issued a Form 483 to Biocon that included 6 observations about the facility.

Then, in June 2018, the FDA issued a Complete Response Letter (CRL) for the company’s insulin glargine, and a representative from Biocon’s partner, Mylan, told The Center for Biosimilars® that the companies “had agreed with FDA to provide additional clinical data in support of the manufacturing site change from Bangalore to Malaysia” and that the CRL was “anticipated” by the partnership.

The biosimilar insulin is approved under the name Semglee in other regulatory territories, however, including Australia and the European Union.

Biocon has also faced regulatory challenges concerning its other facilities; the company received the European Union’s certification of good manufacturing practice for its Bangalore facility in June 2019 after a spate of Form 483s for the site.

In February 2019, the company acknowledged 2 inspection observations—comprising a failure to sanitize a restricted access barrier system and some inadequate conclusions and follow-ups in written records of investigations into unexplained discrepancies at the plant—documented in a Form 483.

Previously, in May 2018, Biocon received a Form 483 noting 7 observations, and in the same week, the drug maker revealed that it had received a preliminary report from a European regulatory inspection of the same facility that resulted in 6 “major” observations. The plant was also the subject of a 2017 Form 483 and a 2017 French National Agency for Medicines and Health Products Safety noncompliance statement.